Medical package and medical device package
Patent Information
- Application Number
- PCT/JP2026/007502
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2025-03-28
- Filing Date
- 2026-02-27
- Publication Date
- 2026-10-01
Smart Images
Figure JP2026007502_01102026_PF_FP_ABST
Abstract
Description
Medical package and medical device package
[0001] The present invention relates to a medical package and a medical device package for accommodating an elongated medical device in a tray.
[0002] Elongated medical devices such as catheters are accommodated in a tray, packaged, sterilized, and then stored or transported (see, for example, Patent Document 1). When an elongated medical device is packaged in a linearly extended state, this method has the advantage that the medical device does not develop a curling habit and is less likely to have an impact on operability. On the other hand, in use, the bulkiness leads to deteriorated handling, and in manufacturing, transportation and storage, it is necessary to allocate larger space for sterilization cabinets, pallets and storage areas, which results in dimensional restrictions.
[0003] US Patent Application No. 2008-023346 Specification
[0004] When an elongated medical device is wrapped annularly for multiple times and packaged, the medical device will develop a curling habit that affects operability. Furthermore, in the case where the medical device comprises an elongated shaft having a curved portion, an expandable expansion body connected to the distal end portion of the shaft, a hub connected to the proximal end portion of the shaft, and a port extending laterally from the hub, winding the shaft is prone to cause mutual interference between components, making it difficult to accommodate the medical device in the tray in a space-saving manner.
[0005] The present invention has been made to solve the above-described problems, and an object thereof is to provide a medical package and a medical device package that can accommodate a medical device in a tray in a space-saving manner while suppressing curling habit of the medical device.
[0006] The above objective is achieved by the invention described in (1) below. (1) The medical package according to the present invention comprises a flexible elongated shaft, an expandable expander connected to the tip of the shaft, a hub connected to the base end of the shaft, and a flexible lateral extension extending laterally from the hub, and a tray capable of holding a medical device having a curved portion formed on the base end side of the expander at the tip of the shaft, wherein the tray has a hub housing portion that can accommodate the hub and is positioned close to the outer edge of the tray, a first straight portion extending linearly from the hub housing portion, a first arc portion extending in an arc shape in the opposite direction from the first straight portion, a second straight portion extending linearly from the first arc portion, and the opposite direction from the second straight portion The present invention features a groove-shaped shaft housing portion that accommodates the shaft by forming a second arc portion extending in an arc shape so as to face a certain direction, and a third straight portion extending linearly from the second arc portion; an extension body housing portion that accommodates the extension body such that the curvature direction of the curved portion of the shaft is the same as the curvature direction of the first arc portion, while the extension body is positioned inside the first arc portion; an intersecting housing groove that intersects with the second arc portion or the third straight portion, and the lateral extension portion can be positioned to extend toward the central portion surrounded by the first arc portion, the second straight portion, the second arc portion, and the third straight portion; and a central housing portion that is continuous with the intersecting housing groove and positioned in the central portion to accommodate the lateral extension portion.
[0007] The medical package described in (1) above has a tray shaft housing section that has straight first, second, and third straight sections, as well as curved first and second circular arc sections, allowing the shaft to be curved only in part and thus suppressing the curling of the shaft. Furthermore, the tray can accommodate the expanded body in the expanded body housing section inside the first circular arc section by aligning the curvature direction of the curved section of the shaft with the curvature direction of the first circular arc section, thus accommodating the expanded body without difficulty and in a space-saving manner. In addition, the tray allows the lateral extension section extending laterally from the hub to reach the central housing section without difficulty, without interfering with the shaft passing through the second circular arc section or the third straight section, thanks to the intersecting housing grooves. As a result, the medical package can accommodate the medical device in the tray in a space-saving manner while suppressing the curling of the device.
[0008] (2) In the medical package described in (1) above, the radius of curvature of the second arc portion may be smaller than the radius of curvature of the first arc portion. This allows the medical package to comfortably position the third straight portion and the expandable body housing portion, which are located further forward than the second arc portion, inside the first straight portion and the second arc portion.
[0009] (3) In the medical package described in (1) or (2) above, the shaft housing portion may be formed such that the depth of the groove becomes shallower from the first straight portion toward the third straight portion. This allows the medical package to house the bulky hub side of the medical device deep in the tray while housing the medical device three-dimensionally. As a result, medical devices, which tend to interfere with each other when the shaft is wound, can be arranged in a space-saving manner without interference between components.
[0010] (4) In the medical package described in any one of (1) to (3) above, the intersecting housing groove may be formed deeper than the shaft housing portion at least at a position where it intersects with the second arc portion or the third straight portion. This allows the medical package to allow the lateral extension housing in the intersecting housing groove to pass under the shaft without interfering with the shaft located in the second arc portion or the third straight portion, and to reach the central housing portion beyond the second arc portion or the third straight portion.
[0011] (5) The medical device held in the tray of the medical package described in any one of (1) to (4) above has an inserter comprising a cylindrical inserter sheath through which the shaft is inserted, an inserter hub connected to the base end of the inserter sheath, and an inserter port extending laterally from the inserter hub, and the third straight section has an inserter housing portion for housing the inserter, and the inserter housing portion may have an inserter hub housing portion with a groove width that is partially larger for housing the inserter hub. As a result, the medical package can house the inserter having an inserter sheath, an inserter hub, and an inserter port together with the medical device in a space-saving manner.
[0012] (6) The medical package described in (5) above may have a tube housing groove that extends from the inserter hub housing toward the central housing and houses the inserter port. This allows the medical package to house the inserter port, which extends laterally from the inserter hub, in the tube housing groove and the central housing.
[0013] (7) In the medical package described in any one of (1) to (6) above, the tray has a side wall surrounding the edge of a receiving plate having a receiving surface in which the shaft receiving portion is formed, and the side wall may have a first side wall cut portion cut out from the receiving surface side so as to expose the hub receiving portion laterally. This makes it easy for a medical professional to insert their hand into the hub receiving portion through the first side wall cut portion and grasp and remove the hub housed in the hub receiving portion.
[0014] (8) The medical device described in any one of (1) to (7) above has a cable, and the tray may have a cable housing for housing the cable at a position different from the central housing in the central part. This allows the medical package to house the cable together with the medical device in a space-saving manner.
[0015] (9) In the medical package described in any one of (1) to (8) above, the medical device may have a cable port extending from the hub to which a cable can be connected, and the tray may have a cable port housing portion that houses the cable port in a manner continuous with the hub housing portion. This allows the medical package to house the cable port extending from the inserter hub in the cable port housing portion.
[0016] (10) In the medical package described in any one of (1) to (9) above, the shaft housing portion may have a protrusion on the inner wall surface of the groove that is on the outside of the winding of the shaft, which can engage with the shaft housed in the shaft housing portion from above. This allows the medical package to prevent the shaft from flying out of the shaft housing portion by engaging with the protrusion, which would otherwise try to return to its original linear shape due to its own elastic force and spread out.
[0017] (11) In the medical package described in (10) above, the protrusion may be formed on at least one of the first arc portion, the second straight portion, or the second arc portion. This allows the medical package to engage the protrusion at at least one point between the tip and base of the shaft, thereby preventing the shaft from popping out of the shaft housing.
[0018] (12) The medical package described in any one of (1) to (11) above has a lid that covers the housing surface of the tray in which the shaft housing portion is formed, the lid has at least one fixing projection on the lid surface that is in contact with the housing surface, and the tray may have at least one fixing recess on the housing surface into which the fixing projection can be fitted. As a result, the medical package can be attached to and detached from the tray by fitting the fixing projection into and out of the fixing recess. Therefore, the medical package can protect the medical device from external forces by fitting the fixing projection of the lid into the fixing recess of the tray containing the medical device, and can also prevent the medical device from falling out of the tray. Furthermore, the medical package can be removed from the tray by removing the lid from the tray.
[0019] (13) In the medical package described in any one of (1) to (12) above, the tray has a side wall surrounding the edge of a receiving plate having a receiving surface in which the shaft receiving portion is formed, and the side wall may have a second side wall cut portion that is cut out from the receiving surface side and covered by the lid. This makes it easy for a medical professional to remove the lid from the tray by inserting their hand between the tray and the lid through the second side wall cut portion.
[0020] (14) The medical device package according to the present invention comprises a medical package according to any one of (1) to (13) above, and the medical device held in the tray of the medical package. As a result, the medical device package can accommodate the medical device in the tray in a space-saving manner while suppressing curling.
[0021] This is a plan view showing the tray, medical device, inserter, and cable of a medical device package according to an embodiment. This is a cross-sectional view along line A-A in Figure 1. This is a plan view showing the medical device according to an embodiment. This is a perspective view showing a portion of the shaft and inserter held in the tray. This is a cross-sectional view along line B-B in Figure 4. This is a perspective view showing a portion of the tray including the side wall. This is a perspective view showing the lid. This is a plan view showing the medical device and inserter removed from the tray.
[0022] Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensional ratios in the drawings may be exaggerated for illustrative purposes and may differ from the actual ratios.
[0023] As shown in Figures 1 to 3, the medical device package 10 according to this embodiment is a package in which the medical device 20 is held in a tray 50 for transport and storage and then placed in a packaging bag 11.
[0024] The medical device package 10 includes a long medical device 20, a tray 50 for holding the medical device 20, a lid 90 for covering the medical device 20 held in the tray 50, a cable 100 (medical device) that can be connected to the medical device 20, and an inserter 40 (medical device). The tray 50 and the lid 90 form the medical package 15.
[0025] As shown in Figures 1, 2, 4, and 5, the medical device 20 is configured to expand a puncture hole formed in the atrial septum of a patient's heart and to perform maintenance procedures to maintain the expanded puncture hole at its size. The medical device 20 includes a long, flexible shaft 21, an expandable body 22 connected to the tip of the shaft 21 and expandable and contractible radially, a hub 23 connected to the proximal end of the shaft 21, a port 24 (lateral extension) extending laterally from the hub 23, and a cable port 25 extending from the hub 23 towards the proximal end.
[0026] The shaft 21 has a long, tubular outer shaft 26 extending from the base to the tip, and a long, tubular inner shaft 27 that can slide axially inside the outer shaft 26. The axial direction is the direction in which the long shaft 21 extends. An electric wire (not shown) for supplying current to an electrode 28 placed on the expansion body 22 for maintenance treatment is arranged on the outer shaft 26. The outer shaft 26 also has a curved portion 29 on the base end side of the connection point with the expansion body 22. The curved portion 29 is formed to allow the direction in which the tip of the shaft 21 faces to be changed. The base end of the inner shaft 27 has a base port 30 fixed to the base end side of the hub 23, through the hub 23, for inserting a guide wire or the like.
[0027] The expander 22 has multiple wires that extend axially and are arranged circumferentially. The wires branch and merge along the axial direction to form a mesh-like structure. The expander 22 is inclined so that it increases radially from both ends in the axial direction toward the center. The expander 22 also has a constricted shape in the axial center where the outer diameter abruptly decreases. The expander 22 has an electrode 28 for maintenance at this constricted position. The electrode 28 supplies current to the puncture hole formed in the atrial septum to maintain the puncture hole at its size. The proximal end of the expander 22 is connected to the tip of the outer shaft 26, and the tip of the expander 22 can receive force (traction force and compressive force) from the inner shaft 27 that protrudes from the tip of the outer shaft 26 toward the tip. Therefore, the expander 22 receives force from the inner shaft 27 which moves axially relative to the outer shaft 26, causing it to extend or contract in the longitudinal direction and contract or expand radially.
[0028] The hub 23 has a housing 31 that is grasped by a medical professional and an operating part 32 that allows the medical professional to move the inner shaft 27 along the axial direction. The housing 31 is fixed to the base end of the outer shaft 26, and the operating part 32 is fixed to the base end of the inner shaft 27.
[0029] Port 24 has a flexible port tube 33 extending laterally from the housing 31 in a direction radially away from the central axis of the shaft 21, and a first three-way stopcock 34 connected to the end of the port tube 33. Port 24 communicates with the lumen of the shaft 21. Therefore, the medical device 20 can prime the lumen of the shaft 21 by supplying physiological saline solution or the like from the first three-way stopcock 34.
[0030] The cable port 25 is the part that receives current from an external source to be supplied to the electrode 28. The cable port 25 has a connection connector 35 that can be connected to an external power supply or cable 100. The cable port 25 protrudes from the base end face of the housing 31 toward the base end. The position in which the cable port 25 protrudes from the housing 31 is not particularly limited, and for example, it may protrude laterally from the housing 31.
[0031] Cable 100 is an extension cable that can be connected between the cable port 25 of the medical device 20 and an external power supply. Note that cable 100 is not required. The cable does not need to be provided on the medical device package 10.
[0032] The inserter 40 includes a cylindrical inserter sheath 41 through which the shaft 21 is inserted, an inserter hub 42 connected to the base end of the inserter sheath 41, and an inserter port 43 extending laterally from the inserter hub 42. The inserter port 43 includes a flexible inserter port tube 44 extending laterally from the inserter hub 42 in a direction radially away from the central axis of the inserter sheath 41, and a second three-way stopcock 45 connected to the end of the inserter port tube 44. The inserter port 43 communicates with the lumen of the inserter sheath 41. The tip of the inserter sheath 41 is located on the base end side of the curved portion 29 of the shaft 21.
[0033] The inserter 40, after being removed from the tray 50, can house the expander 22 in the inserter sheath 41, thereby contracting and holding the expander 22 radially, and can also prime the expander 22 within the inserter sheath 41 by supplying physiological saline solution from the second three-way stopcock 45.
[0034] As shown in Figures 1, 2, 4-6, the tray 50 is formed in a substantially rectangular shape from resin. The tray 50 has a receiving plate 52 with a substantially rectangular receiving surface 51 for accommodating medical devices 20, and side walls 53 surrounding the edge of the receiving plate 52. The side walls 53 rise from a lower part 54 that can be placed on an operating table or the like, and are connected to the receiving plate 52 at an upper part 55 opposite to the lower part 54. The receiving surface 51 extends in a first direction X parallel to the first long side 61 and second long side 62 of the rectangle, and in a second direction Y parallel to the first short side 63 and second short side 64 of the rectangle.
[0035] The housing plate 52 has a housing surface 51 which includes a hub housing section 71 for housing the hub 23, a shaft housing section 72 for housing the shaft 21, an expansion body housing section 73 for housing the expansion body 22, a cross housing groove 74 for housing a part of the port tube 33, a cable port housing section 75 for housing the cable port 25, a central housing section 76 for housing the port 24 and a part of the inserter port 43, a tube housing groove 77 for housing a part of the inserter 40 tube, a cable housing section 78 for housing the cable 100, and a fixing recess 79 for which the lid 90 is fixed. Each housing section, housing groove and recess is formed in a concave shape on the housing surface 51.
[0036] The hub housing portion 71 is positioned close to the first long side 61 and close to the first short side 63 of the housing surface 51. The hub housing portion 71 is formed in a groove shape so as to extend parallel to the first direction X along the first long side 61 from a position close to the first short side 63 toward the second short side 64.
[0037] The shaft housing portion 72 is formed in a groove shape so as to be continuous with the end of the hub housing portion 71 on the second short side 64 in order to accommodate the long shaft 21. The shaft housing portion 72 has a first straight section 65, a first arc section 66, a second straight section 67, a second arc section 68, and a third straight section 69 from the hub housing portion 71 side. The housing plate 52 has a central section 70 surrounded by the first arc section 66, the second straight section 67, the second arc section 68, and the third straight section 69.
[0038] The first straight section 65 is positioned close to the first long side 61 of the housing plate 52 and extends continuously from the end of the hub housing section 71 on the second short side 64 toward the second short side 64. The first straight section 65 extends linearly parallel to the first direction X.
[0039] The first arc portion 66 is continuous with the end of the first straight portion 65 on the second short side 64. The first arc portion 66 is positioned close to the second short side 64 of the housing plate 52 and extends in an arc shape with a substantially constant radius of curvature, gradually moving toward the second long side 62 until it faces the opposite direction (towards the first short side 63).
[0040] The second straight section 67 is positioned close to the second long side 62 of the housing plate 52 and extends continuously from the end of the first arc section 66 on the second long side 62 toward the first short side 63. The second straight section 67 extends linearly parallel to the first direction X.
[0041] The second arc portion 68 is continuous with the end of the second straight portion 67 on the first short side 63. The second arc portion 68 is positioned close to the first short side 63 of the housing plate 52 and extends in an arc shape with a substantially constant radius of curvature, gradually moving toward the first long side 61 and then toward the opposite direction (facing toward the second short side 64). The radius of curvature of the second arc portion 68 is smaller than the radius of curvature of the first arc portion 66.
[0042] The third straight section 69 is positioned close to the first long side 61 of the housing plate 52 and extends continuously from the end of the second arc section 68 on the first long side 61 toward the second short side 64. The third straight section 69 extends linearly parallel to the first direction X. The third straight section 69 is positioned closer to the center of the housing plate 52 than the first straight section 65.
[0043] The third straight section 69 has an inserter housing section 80 that accommodates the inserter 40 through which the shaft 21 is inserted. The inserter housing section 80 has an inserter hub housing section 81 in which the width of the groove is partially enlarged to accommodate the inserter hub 42. The inserter hub housing section 81 is located on the second short side 64 side of the intersecting housing groove 74. The inserter hub housing section 81 is continuous with the intersecting housing groove 74, but it does not have to be continuous. When the inserter hub housing section 81 is located continuous with the intersecting housing groove 74, the tray 50 can position the inserter hub 42 located in the inserter hub housing section 81 close to the port 24 located in the intersecting housing groove 74. As a result, the tray 50 can accommodate the medical device 20 and the inserter 40 in a space-saving manner.
[0044] The groove of the shaft housing portion 72 is formed by two opposing inner wall surfaces 82 that form a pair. The groove width, which is the distance between the two inner wall surfaces 82, widens from the groove bottom toward the upper opening. The shaft housing portion 72 has at least one protrusion 83 (see FIG. 2) protruding toward the inner wall surface 82 on the inner side of the winding on the inner wall surface 82 on the outer side of the winding of the shaft 21. The shaft 21 that is bent and housed in the shaft housing portion 72 tends to jump out from the shaft housing portion 72 along the inner wall surface 82 on the outer side of the winding due to its own restoring force that attempts to return to a linear shape. The protrusion 83 is engageable with the shaft 21 housed in the shaft housing portion 72 from above, and suppresses the shaft 21 from jumping out of the shaft housing portion 72. The protrusion 83 is formed on the first arc portion 66, the second straight portion 67, and the second arc portion 68. The protrusion 83 formed on the first arc portion 66 suppresses the jumping out of the shaft 21 on the second short side 64 side, the protrusion 83 formed on the second straight portion 67 suppresses the jumping out of the shaft 21 on the second long side 62 side, and the protrusion 83 formed on the second arc portion 68 suppresses the jumping out of the shaft 21 on the first short side 63 side. The jumping out of the shaft 21 on the first long side 61 side is suppressed by the hub 23 being held in the hub housing portion 71 and the inserter 40 with the shaft 21 inserted therethrough being held in the inserter housing portion 80.
[0045] Note that the position where the protrusion 83 is formed is not limited to this. Further, the shaft housing portion 72 does not need to have the protrusion 83.
[0046] The shaft housing portion 72 is formed such that the groove depth gradually decreases from the base end of the first straight portion 65 toward the tip end of the third straight portion 69. Note that the groove depth of the shaft housing portion 72 does not need to be changed.
[0047] The shaft housing portion 72 curves the shaft 21 extending from the hub 23 housed in the hub housing portion 71 at the first arc portion 66 and the second arc portion 68, and houses the shaft in a space-saving manner.
[0048] The expandable body accommodating portion 73 is formed continuously from an end portion of the third straight portion 69 on the second short side 64 side closer to the central portion 70 side than the first arc portion 66, for accommodating the distal end portion including the curved portion 29 of the shaft 21 and the expandable body 22. The expandable body accommodating portion 73 is formed so as to widen toward the second long side 62 while extending from the end portion of the third straight portion 69 on the second short side 64 side toward the second short side 64 side. The expandable body accommodating portion 73 accommodates the distal end portion of the shaft 21 and the expandable body 22 such that the expandable body 22 is disposed closer to the central portion 70 side than the first arc portion 66, while aligning the bending direction of the curved portion 29 of the shaft 21 with the bending direction of the first arc portion 66.
[0049] The cross accommodation groove 74 is a groove extending along the second direction Y so as to continuously extend from the hub accommodation portion 71 toward the central portion 70. The cross accommodation groove 74 intersects a portion of the second arc portion 68 close to the first long side 61 or the third straight portion 69. The cross accommodation groove 74 is formed deeper than the shaft accommodation portion 72 at a position intersecting the second arc portion 68 or the third straight portion 69 (see FIG. 5). Incidentally, the depth of the groove of the shaft accommodation portion 72 becomes shallower from the proximal end of the first straight portion 65 toward the distal end of the third straight portion 69. Therefore, the cross accommodation groove 74 deeper than the second arc portion 68 or the third straight portion 69 can be easily formed from the hub accommodation portion 71. The cross accommodation groove 74 accommodates the port tube 33 extending from the hub 23 toward the central portion 70. Since the cross accommodation groove 74 is formed deeper than the intersecting shaft accommodation portion 72, the accommodated port tube 33 can pass under the shaft 21 without interfering with the shaft 21 disposed on the second arc portion 68 or the third straight portion 69, and can reach the central portion 70 side beyond the second arc portion 68 or the third straight portion 69.
[0050] The cable port accommodating portion 75 is a recess continuous from an end portion of the hub accommodating portion 71 on the first short side 63 side toward the first short side 63 side. The cable port accommodating portion 75 is disposed between the hub accommodating portion 71 and the first short side 63. The cable port accommodating portion 75 accommodates the cable port 25 extending from the hub 23.
[0051] The tube housing groove 77 is a groove that extends along the second direction Y so as to be continuous with the inserter hub housing portion 81 toward the central portion 70. The tube housing groove 77 houses the inserter port tube 44 of the inserter port 43 that extends laterally from the inserter hub 42.
[0052] The central housing section 76 is a recess formed in a position adjacent to the third straight section 69 of the central section 70, and is continuous with the intersecting housing groove 74 and the tube housing groove 77. The central housing section 76 accommodates the port 24 extending from the intersecting housing groove 74 and the inserter port 43 extending from the tube housing groove 77.
[0053] The cable housing section 78 is a groove formed in an annular shape, resembling an oval, and is located at a different position from the central housing section 76 in the central section 70. The shape of the cable housing section 78 is not limited. For example, the shape of the cable housing section 78 may be a groove formed in an annular shape, resembling a circle, ellipse, or square, or it may be a recess that is not an annular shape but an oval, circle, ellipse, or square. Alternatively, the tray 50 may not have a cable housing section 78. The cable housing section 78 accommodates the wound cable 100.
[0054] The fixing recess 79 is at least one recess formed in the receiving surface 51. In this embodiment, one fixing recess 79 is arranged near each of the four corners of the substantially rectangular receiving surface 51. The fixing recess 79 is fitted into the fixing projection 91 formed on the lid 90, thereby fixing the lid 90 to the tray 50.
[0055] The side wall 53 has a first side wall cut portion 56 and at least one second side wall cut portion 57.
[0056] The first sidewall cutout 56 is formed on the first long side 61 adjacent to the hub housing 71, by cutting out from the housing surface 51 (upper part 55) side, thereby exposing the hub housing 71 to the side. The first sidewall cutout 56 makes it easier for medical personnel to grasp the hub 23 housed in the hub housing 71. Furthermore, with the lid 90 fixed to the tray 50, the first sidewall cutout 56 allows medical personnel to easily position their hand between the tray 50 and the lid 90 by inserting their hand into the first sidewall cutout 56, making it easier to remove the lid 90 from the tray 50. Note that the tray 50 does not necessarily have to have the first sidewall cutout 56.
[0057] The second sidewall cut portion 57 is formed on the first short side 63 by cutting out from the receiving surface 51 (upper part 55) side. With the lid 90 fixed to the tray 50, the second sidewall cut portion 57 allows medical personnel to easily position their hand between the tray 50 and the lid 90 by inserting their hand into the second sidewall cut portion 57, making it easier to remove the lid 90 from the tray 50. In this embodiment, there is one second sidewall cut portion 57, but there may be two or more. Note that the tray 50 does not have to have a second sidewall cut portion 57.
[0058] As shown in Figures 3 and 7, the lid 90 is a plate-shaped member that covers the receiving surface 51 of the tray 50, protects the medical device 20, cable 100, and inserter 40 held in the tray 50, and prevents the medical device 20, cable 100, and inserter 40 from falling out of the tray 50. The lid 90 has a lid surface 92 that covers the receiving surface 51, and at least one (four in this embodiment) fixing protrusion 91 that fits into the fixing recess 79 of the receiving surface 51.
[0059] The tray 50 and lid 90 are formed from a resin material such as polypropylene, polystyrene, or polyethylene terephthalate.
[0060] As shown in Figure 3, the packaging bag 11 is formed into a bag shape by overlapping a flexible and pliable rectangular first sheet 12 and a flexible and pliable rectangular second sheet 13, and bonding or fusing the edges. The first sheet 12 is a flexible resin film, preferably transparent or translucent. The second sheet 13 is made of a nonwoven fabric or the like, and is preferably a sheet that allows gas to pass through but does not allow bacteria to pass through. The packaging body having the second sheet 13 allows a sterilization gas (e.g., ethylene oxide gas) to pass through the second sheet 13, making it possible to sterilize the medical device 20, inserter 40 and cable 100 contained inside and sealed with gas. The medical device 20, inserter 40 and cable 100 contained in the packaging body may be sterilized by gamma ray sterilization or electron beam sterilization, etc. In this case, the second sheet 13 does not have to be gas permeable and may be made of a resin material, for example.
[0061] Next, the method of using the medical device package 10 will be described. When a medical professional uses the medical device 20, they first tear open the packaging bag 11. Next, the medical professional removes the medical device 20, inserter 40, and cable 100, which are housed in the tray 50 and lid 90, from the packaging bag 11. Next, the medical professional inserts their hands into the first side wall cutout 56 and the second side wall cutout 57 and applies force to the lid 90 in a direction that separates it from the tray 50. As a result, the fixing protrusion 91 of the lid 90 detaches from the fixing recess 79 of the tray 50, and the lid 90 is removed from the tray 50.
[0062] Next, the medical professional inserts their hand into the hub housing 71 using the first side wall cutout 56. Then, the medical professional grasps the hub 23 and inserter hub 42, etc., and removes the medical device 20 and inserter 40 from the tray 50. Furthermore, the medical professional removes the cable 100 from the cable housing 78 of the tray 50 and connects the cable 100 to the cable port 25. As shown in Figure 8, the medical device 20 placed on the operating table has coiling in only two limited places where it was housed in the first arc portion 66 and the second arc portion 68 of the tray 50. This makes it easy for the medical professional to grasp the base and tip of the medical device 20 simultaneously, improving its handling in the operating room. After this, the medical professional can perform the desired medical procedure using the medical device 20, inserter 40, and cable 100.
[0063] As described above, the medical package 15 in this embodiment has a flexible, elongated shaft 21, an expandable extension 22 connected to the tip of the shaft 21, a hub 23 connected to the base end of the shaft 21, a flexible lateral extension (port 24) extending laterally from the hub 23, and a tray 50 capable of holding a medical device 20 having a curved portion 29 formed on the base end side of the extension 22 at the tip of the shaft 21, wherein the tray 50 has a hub housing portion 71 capable of accommodating the hub 23 positioned close to the outer edge of the tray 50, a first straight portion 65 extending linearly from the hub housing portion 71, a first arc portion 66 extending in an arc shape in the opposite direction from the first straight portion 65, and a first arc portion 66 extending linearly from the first arc portion 66 The shaft housing portion 72 has a groove shape for housing the shaft 21, forming a second straight section 67, a second arc section 68 extending in an arc shape from the second straight section 67 in the opposite direction, and a third straight section 69 extending linearly from the second arc section 68; the extension body housing portion 73 houses the shaft 21 such that the curvature direction of the curved section 29 of the shaft 21 is the same as the curvature direction of the first arc section 66, while the extension body 22 is positioned inside the first arc section 66; the intersecting housing groove 74 intersects with the second arc section 68 or the third straight section 69, and the lateral extension can be positioned to extend toward the central section 70 surrounded by the first arc section 66, the second straight section 67, the second arc section 68, and the third straight section 69; and the central housing portion 76 is positioned in the central section 70, continuous with the intersecting housing groove 74, and houses the lateral extension. As a result, the medical package 15 has a shaft housing section 72 in the tray 50 that has straight first straight section 65, second straight section 67, and third straight section 69, as well as curved first arc section 66 and second arc section 68, so that the shaft 21 is only partially curved when housing it, thus suppressing the curling of the shaft 21. In addition, the tray 50 can accommodate the expanded body 22 in the expanded body housing section 73 located inside the first arc section 66, by aligning the curvature direction of the curved section 29 of the shaft 21 with the curvature direction of the first arc section 66, allowing the expanded body 22 to be housed comfortably and in a space-saving manner. Furthermore, the tray 50 allows the laterally extending portion from the hub 23 to reach the central housing section 76 without interfering with the shaft 21 passing through the second arc section 68 or the third straight section 69, thanks to the intersecting housing groove 74.Therefore, the medical package 15 allows the medical device 20 to be stored in the tray 50 in a space-saving manner while suppressing curling.
[0064] Furthermore, the radius of curvature of the second arc portion 68 is smaller than the radius of curvature of the first arc portion 66. As a result, the medical package 15 can comfortably position the third straight portion 69 and the expandable body housing portion 73, which are located closer to the tip than the second arc portion 68, inside the first straight portion 65 and the second arc portion 68.
[0065] Furthermore, the shaft housing section 72 is formed such that the groove depth decreases from the first straight section 65 to the third straight section 69. As a result, the medical package 15 can house the bulky hub 23 side of the medical device 20 deep within the tray 50, while also housing the medical device 20 three-dimensionally. This allows the medical device 20, whose components tend to interfere with each other when the shaft 21 is wound around it, to be arranged comfortably and in a space-saving manner without interfering with each other.
[0066] Furthermore, the intersecting housing groove 74 is formed deeper than the shaft housing portion 72 at least at the position where it intersects with the second arc portion 68 or the third straight portion 69. As a result, the medical package 15 can have the lateral extension portion (port 24) housed in the intersecting housing groove 74 pass under the shaft 21 located in the second arc portion 68 or the third straight portion 69 without interfering with the shaft 21, and reach the central housing portion 76 beyond the second arc portion 68 or the third straight portion 69.
[0067] Furthermore, the medical device held in the tray 50 of the medical package 15 has an inserter 40 comprising a cylindrical inserter sheath 41 through which a shaft 21 is inserted, an inserter hub 42 connected to the base end of the inserter sheath 41, and an inserter port 43 extending laterally from the inserter hub 42. The third straight section 69 has an inserter housing section 80 that houses the inserter 40, and the inserter housing section 80 has an inserter hub housing section 81 with a groove that is partially wider to house the inserter hub 42. As a result, the medical package 15 can house the inserter 40, which has the inserter sheath 41, the inserter hub 42, and the inserter port 43, together with the medical device 20 in a space-saving manner.
[0068] Furthermore, the medical package 15 has a tube housing groove 77 that extends from the inserter hub housing section 81 toward the central housing section 76 and accommodates the inserter port 43. This allows the medical package 15 to accommodate the inserter port 43, which extends laterally from the inserter hub 42, in the tube housing groove 77 and the central housing section 76.
[0069] Furthermore, the tray 50 has side walls 53 surrounding the edge of the housing plate 52 which has a housing surface 51 in which the shaft housing portion 72 is formed, and the side walls 53 have a first side wall cut portion 56 that is cut out from the housing surface 51 side so as to expose the hub housing portion 71 to the side. As a result, the medical package 15 makes it easy for medical personnel to insert their hands into the hub housing portion 71 through the first side wall cut portion 56 and grasp and remove the hub 23 housed in the hub housing portion 71.
[0070] Furthermore, the medical device has a cable 100, and the tray 50 has a cable housing section 78 for housing the cable 100 at a position different from the central housing section 76 of the central section 70. As a result, the medical package 15 can house the cable 100 together with the medical device 20 in a space-saving manner.
[0071] Furthermore, the medical device 20 has a cable port 25 extending from the hub 23 to which the cable 100 can be connected, and the tray 50 has a cable port housing section 75 that houses the cable port 25, continuous with the hub housing section 71. As a result, the medical package 15 can house the cable port 25 extending from the inserter hub 42 in the cable port housing section 75.
[0072] Furthermore, the shaft housing portion 72 has a projection 83 on the inner wall surface 82 of the groove that is on the outside of the winding of the shaft 21, which can engage with the shaft 21 housed in the shaft housing portion 72 from above. As a result, the medical package 15 can prevent the shaft 21, which would otherwise expand and try to return to its original linear shape due to its own elastic force within the shaft housing portion 72, from flying out of the shaft housing portion 72 by engaging with the projection 83.
[0073] Furthermore, the protrusion 83 is formed on at least one of the first arc portion 66, the second straight portion 67, or the second arc portion 68. This allows the medical package 15 to engage the protrusion 83 at at least one point between the tip and base of the shaft 21, thereby preventing the shaft 21 from popping out of the shaft housing portion 72.
[0074] Furthermore, the medical package 15 has a lid 90 that covers the storage surface 51 where the shaft storage portion 72 of the tray 50 is formed, and the lid 90 has at least one fixing projection 91 on the lid surface 92 that contacts the storage surface 51, and the tray 50 has at least one fixing recess 79 on the storage surface 51 into which the fixing projection 91 can be fitted. As a result, the medical package 15 can attach and detach the lid 90 to the tray 50 by fitting the fixing projection 91 into and out of the fixing recess 79. Therefore, by fitting the fixing projection 91 of the lid 90 into the fixing recess 79 of the tray 50 containing the medical device 20, the medical package 15 can protect the medical device 20 from external forces with the tray 50 and the lid 90, and can also prevent the medical device 20 from flying out of the tray 50. Then, by removing the lid 90 from the tray 50, the medical package 15 can remove the medical device 20 from the tray 50.
[0075] Furthermore, the tray 50 has side walls 53 surrounding the edge of the receiving plate 52 which has a receiving surface 51 in which the shaft receiving portion 72 is formed, and the side walls 53 have a second side wall cut portion 57 which is cut out from the receiving surface 51 side and covered by the lid 90. As a result, the medical package 15 makes it easy for medical personnel to insert their hand between the tray 50 and the lid 90 through the second side wall cut portion 57 and remove the lid 90 from the tray 50.
[0076] Furthermore, the medical device package 10 according to this embodiment comprises a medical package 15 and a medical device 20 held in a tray 50 of the medical package 15. This allows the medical device package 10 to accommodate the medical device 20 in the tray 50 in a space-saving manner while suppressing curling.
[0077] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. For example, the lateral extension portion extending laterally from the hub 23 of the medical device 20 does not have to be a priming port 24, but may be, for example, a cable port 25. Also, the medical device 20 does not have to be a device used for treating the atrial septum of the heart.
[0078] This application is based on Japanese Patent Application No. 2025-056115, filed on March 28, 2025, and its disclosures are referenced and incorporated as a whole.
[0079] 10 Medical device package 15 Medical package 20 Medical device 21 Shaft 22 Expander 23 Hub 24 Port 25 Cable port 29 Curved section 40 Inserter (medical device) 41 Inserter sheath 42 Inserter hub 43 Inserter port 50 Tray 51 Housing surface 52 Housing plate 53 Side wall 56 First side wall cut section 57 Second side wall cut section 65 First straight section 66 First arc section 67 Second straight section 68 Second arc section 69 Third straight section 70 Central section 71 Hub housing section 72 Shaft housing section 73 Expander housing section 74 Crossing housing groove 75 Cable port housing section 76 Central housing section 77 Tube housing groove 78 Cable housing section 79 Fixing recess 80 Inserter housing section 81 Inserter hub housing 82 Inner wall surface 83 Protrusion 90 Lid 91 Fixing protrusion 92 Lid surface 100 Cable (medical device) X First direction Y Second direction
Claims
1. A medical package having a tray capable of holding a medical device, the tray having a curved portion formed on the base end of the shaft, which is closer to the base end than the extension at the tip of the shaft, the tray having a hub housing portion that can accommodate the hub and is positioned close to the outer edge of the tray, and a groove-shaped shaft housing portion that accommodates the shaft by forming a first straight portion extending linearly from the hub housing portion, a first arc portion extending in an arc shape in the opposite direction from the first straight portion, a second straight portion extending linearly from the first arc portion, a second arc portion extending in an arc shape in the opposite direction from the second straight portion, and a third straight portion extending linearly from the second arc portion, A medical package characterized by comprising: an extension housing portion that houses the extension body such that the curvature direction of the curved portion of the shaft is the same as the curvature direction of the first arc portion, and the extension body is positioned inside the first arc portion; an intersecting housing groove that intersects with the second arc portion or the third straight portion, and the lateral extension portion can be positioned to extend toward the central portion surrounded by the first arc portion, the second straight portion, the second arc portion, and the third straight portion; and a central housing portion that is continuous with the intersecting housing groove and positioned in the central portion to house the lateral extension portion.
2. The medical package according to claim 1, characterized in that the radius of curvature of the second arc portion is smaller than the radius of curvature of the first arc portion.
3. The medical package according to claim 1 or 2, characterized in that the shaft housing portion is formed such that the depth of the grooves becomes shallower from the first straight portion toward the third straight portion.
4. The medical package according to claim 1 or 2, characterized in that the intersecting housing groove is formed deeper than the shaft housing portion at least at a position where it intersects with the second arc portion or the third straight portion.
5. The medical device held in the tray of the medical package has an inserter comprising a cylindrical inserter sheath through which the shaft is inserted, an inserter hub connected to the base end of the inserter sheath, and an inserter port extending laterally from the inserter hub, wherein the third straight section has an inserter housing portion for housing the inserter, and the inserter housing portion has an inserter hub housing portion having a groove width that is partially larger for housing the inserter hub, as described in claim 1 or 2.
6. The medical package according to claim 5, characterized in that it has a tube housing groove that extends from the inserter hub housing portion toward the central housing portion and houses the inserter port.
7. The medical package according to claim 1 or 2, wherein the tray has a side wall surrounding the edge of a receiving plate having a receiving surface in which the shaft receiving portion is formed, and the side wall has a first side wall cut portion cut out from the receiving surface side so as to expose the hub receiving portion laterally.
8. The medical package according to claim 1 or 2, wherein the medical device has a cable, and the tray has a cable housing portion for housing the cable at a position different from the central housing portion in the central part.
9. The medical package according to claim 1 or 2, wherein the medical device has a cable port extending from the hub to which a cable can be connected, and the tray has a cable port housing portion that houses the cable port, continuous with the hub housing portion.
10. The medical package according to claim 1 or 2, characterized in that the shaft housing portion has a projection on the inner wall surface of the groove that is on the outside of the winding of the shaft, which can engage with the shaft housed in the shaft housing portion from above.
11. The medical package according to claim 10, characterized in that the convex portion is formed on at least one of the first arc portion, the second straight portion, or the second arc portion.
12. The medical package according to claim 1 or 2, wherein the medical package has a lid that covers the housing surface of the tray in which the shaft housing portion is formed, the lid has at least one fixing projection on the surface in contact with the housing surface, and the tray has at least one fixing recess on the housing surface into which the fixing projection can be fitted.
13. The medical package according to claim 12, wherein the tray has a side wall surrounding the edge of a receiving plate having a receiving surface in which the shaft receiving portion is formed, and the side wall has a second side wall cut portion that is cut out from the receiving surface side and covered by the lid.
14. A medical device package comprising: a medical package according to claim 1; and the medical device held in the tray of the medical package.